Senior Project Engineer, Development (Medical Devices)

Location: Audubon, Pennsylvania, United States; onsite

Company

hirify.global develops surgical solutions and advanced technologies for patients with musculoskeletal disorders, working with surgeons, healthcare providers, researchers, and educators.

What you will do

• Lead engineering activities for spine product lines from concept and design through prototyping, development testing, verification, validation, manufacturing, FDA approval, product introduction, and post-introduction monitoring.
• Gather feedback from surgeons and customers and translate clinical needs into functional and design specifications.
• Create and maintain project plans and FDA-compliant Design History Files while managing schedules, tasks, quality-system compliance, and regulatory requirements.
• Design and develop instruments and implants using Creo, partnering with prototype shops and external vendors for rapid prototyping and evaluation.
• Collaborate with marketing, product management, operations, suppliers, and regulatory teams on forecasts, market plans, regulatory applications, manufacturing, purchasing, and product launches.
• Research competitors and industry developments, support sales training and customer interactions, and address product change requests after launch.

Requirements

• At least five years of mechanical design engineering experience, preferably in the medical device field.
• Bachelor’s degree in Mechanical Engineering or a similar discipline.
• Proficiency in Creo software for design and drafting.
• Proven ability to lead people, take initiative, multitask, and work effectively in a fast-paced, deadline-driven environment.
• Strong organization, attention to detail, teamwork, reporting, budgeting, and Microsoft Office skills.
• Ability to represent company principles professionally when working with customers, investors, regulatory agencies, industry peers, suppliers, and other stakeholders.

Culture & Benefits

• Innovation-focused work aimed at improving patient care and surgical outcomes.
• Customer-focused culture with an emphasis on responsiveness to surgeons and healthcare providers.
• Values centered on teamwork, accountability, respect, energy, and results.
• Commitment to ethical business practices, regulatory compliance, inclusion, and equal employment opportunity.